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Request a proposal

How the fee is set

Annual fee by device class, from €800 for class I to €2,000 for class III. No setup fee. Changing representative costs €150. Rates are fixed for three years from signature.

What happens next

We check your device list and the Annex VIII class, send the proposal with a draft mandate under Article 11(3), and after signature link your EUDAMED registration to our authorised representative SRN TR-AR-000057550.

Our offices

İstanbul

Zuhal Cad. Ritim İstanbul B Blok No: 44,

Maltepe - TÜRKİYE
regulatory@medexeurep.com

+90 546 104 8101

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Gdańsk
Aleja Grunwaldzka 347

80-309

Gdańsk - POLAND
info@medexeurep.com

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Tell us about your devices. Within one business day you receive a fixed-price written proposal and a draft Article 11 mandate.

Appoint a representative

Send your device list for a written quote

Highest device class
Conformity status
Current EU authorised representative
Services you need
Target date for placing on the EU market
Month
Day
Year
Device classes in scope (select all that apply)
Device characteristics (select all that apply)
Your role in the supply chain
Documents you can share
Target markets
Regulation(s) your devices fall under
Preferred contact method

Share a folder link with your device list, DoC, certificates, labels and IFU, or email them to regulatory@medexeurep.com.

How did you find us?
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